Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400, Thailand
NCT Number: NCT04818450
The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ratchathewi, Bangkok, 10400, Thailand
Up to 61% of critically ill patients have sleep deprivation in ICU. Sleep deprivation can cause delirium and lead to prolonged ICU length of stay and mechanical ventilator days. However, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in ICU patients. There were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. Therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. The objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gabapentin 100-300 mg is given to the intervention group
Other names: Gabapentin group
Time frame: at least 3 consecutive days after randomization
Slow-wave sleep period or deep sleep period
Time frame: During hospital stay or death or a maximum of 90 days
Rates of all-cause mortality during hospital stay
Time frame: During ICU stay or death or a maximum of 28 days
Days alive and not stay in ICU
Time frame: During ICU stay or death or a maximum of 28 days
Day alive and free of mechanical ventilator
Time frame: During hospital stay or death or a maximum of 90 days
Days alive and not stay in hospital
Time frame: During ICU stay or death or a maximum of 28 days
Number of patients who had self-extubation during ICU stay
Time frame: During ICU stay or death or a maximum of 28 days
Times per patient-days of sleep deprivation during ICU stay
Time frame: During ICU stay or death or a maximum of 28 days
Days alive and not having delirium
Time frame: At day 0, 1, 3, and 5 after randomization
IGF-1 level
Mahidol University
Other
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.
Acronym: GASWAC
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